Updated: December 29, 2025

Location: Warsaw, MZ, Poland

Job ID: 25104433

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full‑Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels they belong.

Job Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management activities, and close‑out visits (on‑site or remotely) ensuring regulatory, ICH‑GCP, and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance; evaluates overall site performance, communicates/escalates serious issues, and develops action plans.
• Verifies the informed consent process is properly conducted and documented; protects subject confidentiality; assesses factors affecting safety and data integrity such as protocol deviations, violations, and pharmacovigilance issues.
• Assesses site processes per the Clinical Monitoring/Site Management Plan; reviews source documents and medical records; verifies CRF data accuracy and completeness; resolves queries; ensures electronic data capture compliance.
• Manages investigational product inventory, reconciliation, storage, and security; ensures IP dispensation and administration follows protocol; addresses risks related to blinded or randomized IP. Applies GCP and local regulations to ensure proper labeling, import, release, and return of IP.
• Reviews the Investigator Site File for accuracy, timeliness, and completeness; reconciles it with the Trial Master File; educates the site on archiving requirements.
• Documents activities via letters, trip reports, and logs; supports recruitment, retention, and awareness strategies; enters data into tracking systems to maintain observation and action item status.
• Understands project scope, budgets, and timelines; manages site‑level activities and communication to meet objectives and deliverables.
• Acts as primary liaison with site personnel or collaborates with Central Monitoring Associate; ensures all team members are trained and compliant.
• Prepares for and attends Investigator Meetings and sponsor face‑to‑face meetings; participates in global monitoring project staff meetings and attends required training sessions.
• Provides guidance toward audit readiness and supports audit preparation.
• Maintains knowledge of ICH‑GCP guidelines and other regulations; completes required training. Additional responsibilities include site support throughout the study lifecycle, knowledge of real‑world late phase study designs, chart abstraction, data collection, collaboration with sponsor affiliates, medical science liaisons, and local staff; may train junior staff; identifies out‑of‑scope activities; suggests potential sites based on local knowledge.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Good computer skills with the ability to embrace new technologies.
• Excellent communication, presentation, and interpersonal skills.
• Ability to manage travel of up to 75% on a regular basis.
• US ONLY: Requires compliance with certain medical and personal information requests for site access; failure may result in employment risk.

Legal and Equal Employment Opportunity Statements

Tasks, duties, and responsibilities listed are not exhaustive. The Company may assign other duties at its discretion. The Company recognizes the rights of employees under the Americans with Disabilities Act and will provide reasonable accommodations when appropriate. The Company is committed to compliance with the EU Equality Directive and the U.S. Equal Employment Opportunity laws. The Company offers equal opportunity to all applicants and employees, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or any other protected class.

Get to Know Syneos Health

Over the past 5 years, we have worked with 94% of all novel FDA‑approved drugs, 95% of EMA authorizations, and more than 200 studies across 73,000 sites and 675,000+ trial patients.

Learn more at SyneosHealth.com.